A simple, rapid and accurate reversed-phase HPLC method was developed and validated for the simultaneous determination of lamivudine (LMV) and zidovudine (ZDV) in tablet dosage form and applied for stress degradation studies. The proposed RP-HPLC method utilizes qualisilgold C18, 5 µm, 250 mm×4.6 mm i.d. column, mobile phase consisting of methanol and water in the proportion of 30:70 (v/v) at a flow rate of 1 ml/min and UV detection at 266 nm using photodiode array detector. The linearity of the proposed method was investigated in the range of 2-24 µg/ml (r = 0.999) for LMV and 3-48 µg/ml (r = 0.999) for ZDV. The limit of detection was 0.01 µg/ml and 0.1 µg/ml for LMV and ZDV. The limits of quantification were 0.05 µg/ml and 0.3 µg/ml for LMV and ZDV, respectively. LMV, ZDV and their combination were exposed to hydrolytic, oxidative, thermal and photolytic stress conditions as recommended by ICH guidelines. Degradation products produced as a result of stress studies did not interfere with the detection of LMV and ZDV and can be applied to the analysis of samples obtained during stability studies.
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